Job Description:
Cambrex
HIPO Operator
US-IA-Charles City
Job ID: 2024-3915
Type: Regular Full-Time
# of Openings: 1
Category: Operations
Cambrex - Charles City
Overview
Under general supervision of the Supervisor, operates and set up the equipment used in processing chemicals and pharmaceutical products t to complete the successful manufacture of qualified product.
Responsibilities
The WC 35/38/51 operator duties include but are not limited to the following:
- Operate batch type reactors, centrifuges, filters, dryers, isolators, mills, micronizers and other supporting equipment involved in production of products in the WC 35/38/51 equipment/suites, all according to designated procedures.
- Be able to work using isolators and/or glove bags as needed for processing and sampling.
- Work with High Potency equipment / processes as needed including kilo lab equipment as necessary.
- Monitor the equipment; setting controls on valves, vacuums, pumps, pressures, etc., according to designated procedures to achieve desired results.
- Maintains accurate records in the log books of all process equipment.
- Monitors the process variables and makes process control adjustments to maintain the proper process control. Use manual and computer controlled devices to monitor and control the process.
- Clean all equipment used (boil, scrape or scrub out) following designated procedures.
- Assist in training new WC35/38/51 Operators or others assigned to assist with production in the work centers.
- Drum compounds and hazardous waste; label according to set standards; transport to assigned areas.
- Assure area is kept clean and all precautions are taken to prevent environmental spills and control discharge to WWTP at acceptable limits.
- Complete environmental monitoring samples for all work centers
- Interpret results and monitor processes using computer controlled devices.
- Troubleshoot production line and equipment problems in a safe and effective manner. Including performing minor maintenance and preventive maintenance as needed.
- Complete line entry, confined space, and hot work permits.
- Assist in writing and updating process procedures and SOP’s.
- Adhere to all EPA, DEA, FDA and cGMP regulations as they relate to the operation of the manufacturing facility.
- Take samples for in-process and Quality Control analysis.
- Assist with kilo lab duties as assigned
- Perform laboratory tests on process samples and act on results.
- Operators will be required to gown in full personal protective equipment, including respirators and Tyvek suits.
- Operators will need to use isolators and flexible containment.
- Other activities relating to assigned departmental mission not specifically detailed in this section.
"All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned."
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